Tuesday, May 4, 2010

Great New Article by Marcia Angell

Marcia Angell has done it again, this time in the pages of the Boston Review, where she has just published this article entitled "Big Pharma, Bad Medicine: How corporate dollars corrupt research and education." It may seem that there is little more to learn about how enmeshed academia has become with industry, but, as she did in her classic book, The Truth About the Drug Companies, Dr. Angell has breathed new life into the issue and should inspire us to keep fighting the good fight.

To whet your appetite, I'll quote her conclusion, in which she recommends three basic reforms:

"For some time now, I’ve been recommending these three essential reforms:

First, members of medical school faculties who conduct clinical trials should not accept any payments from drug companies except research support, and that support should have no strings attached. In particular, drug companies should have no control over the design, interpretation, and publication of research results. Medical schools and teaching hospitals should rigorously enforce this rule and should not themselves enter into deals with companies whose products are being studied by members of their faculty.

Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education. Other professions pay their own way, and there is no reason for the medical profession to be different in this regard.

Finally, academic medical centers that patent discoveries should put them in the public domain or license them inexpensively and non-exclusively, as Stanford does with its patent on recombinant DNA technology based on the work of Stanley Cohen and Herbert Boyer. Bayh-Dole is now more a matter of seeking windfalls than of transferring technology. Some have argued that it actually impedes technology transfer by enabling the licensing of early discoveries, which encumbers downstream research. Though the legislation stipulates that drugs licensed from academic institutions be made “available on reasonable terms” to the public, that provision has been ignored by both industry and academia. I believe medical research was every bit as productive before Bayh-Dole as it is now, despite the lack of patents. I’m reminded of Jonas Salk’s response when asked whether he had patented the polio vaccine. He seemed amazed at the very notion. The vaccine, he explained, belonged to everybody. “Could you patent the sun?” he asked.

I’m aware that my proposals might seem radical. That is because we are now so drenched in market ideology that any resistance is considered quixotic. But academic medical centers are not supposed to be businesses. They now enjoy great public support, and they jeopardize that support by continuing along the current path.

And to those academic researchers who think the current path is just fine, I have this to say: no, it is not necessary to accept personal payments from drug companies to collaborate on research. There was plenty of innovative research before 1980—at least as much as there is now—when academic researchers began to expect rewards from industry. And no, you are not entitled to anything you want just because you’re very smart. Conflicts of interest in academic medicine have serious consequences, and it is time to stop making excuses for them."

17 comments:

She's right of course, but she left out advertising that supports journals.

I guess when the insurance companies start reimbursing $500 for a psychotherapy session we will still be able to pay our own way for continuing education. But will all those psychologists still want to prescribe?

I agree with what she says, but too little too late. How deep does the rabbit hole go? It goes into the brain of every psychiatrist, every therapist from other professions and every patient who believes in the "chemical imbalance" nonsense, the DSM and the whole shebang. It is IMPOSSIBLE to fight the tide.

It's good she's saying this and maybe in 20 years medicine will be back on the right track but I DON'T HAVE 20 years to wait. Bills are due NOW. And I'm still a lone ranger out there.

Thanks for bringing the article to our attention. I agree with her points.

I don't know who I'm quoting here but "Its very difficult to make a man see something, when his income depends on him not seeing it." I therefore expect the usual complaints that there is no clear "proof" to her arguments, blah blah blah. Too bad there isn't a medication to treat greed.

Has anyone attempted to publish a reasonable retort to this explaining why the current system is not a problem? Frankly for psych, this will be increasingly a much smaller issue. Many of the major pharma players are exiting the psych drug playing field and current predictions for the next decade for blockbuster drugs do not include any psych meds. I think the sun is setting on the psych-pharma empire.It cannot die soon enough. There will be no more new Beiderman's or Nemeroff's.

Most of us Non-Medical Doctor therapists have been paying out of pocket for continuing Education. I pay about 1k a year for seminars to maintain my License. My income typically doesn't exceed mid 30's in a year, and so its laughable to even consider any of the "Destination" seminars that cost thousands. Home study, and local seminars work just fine for education, you don't need to travel to learn.

Why has it become so acceptable to so many that the corruption of their profession ethically, from small "gifts/bribes" to having research funded basically by those who have vested interest in having outcomes suit their financial purposes?

I believe this quote is what you were referring to Joseph. “It is difficult to get a man to understand something when his salary depends on his not understanding it.”--Upton Sinclair

The funny thing is for most of us Masters level therapists, is that the pay is so lousy, I made nearly as much money bartending part-time and working a minimum wage graduate assistantship during college as I have working at college counseling centers, community counseling centers and social service agencies. Economically, most of the PH.D's and Master's degrees don't end up paying off financially, so many of us tend to focus on the helping aspect to help make us feel good about working in a profession that is often thankless and keeps most of us in the lower-middle class. So when I listen to some complaints, by many who make a lot of money, and after their student loan debts are paid off will do quite well for themselves medicating patients--its frustrating. I know a couple MD's and they have endless opportunity to make money if they choose to do so, since their is such a shortage--and they basically can do whatever they want, they have no real oversight--they are top dogs and basically just have to make sure clients don't die, but even when clients suffer fairly severe side effects--no big deal, just titrate or try one of the new drugs that Pharma Rep's are pushing on them.

@ Joseph Arpaia, MD: The line you quoted is a paraphrase of a classic Upton Sinclair dictum, which goes "It is difficult to get a man to understand something, when his salary depends upon his not understanding it!"

That may explain the cognitive pathologies of lobbyists and company men or women, but academic clinical scientists already have a salary, so they have no real excuse for putting lipstick on pigs.

Dr John, your comment gives me much more hope than the possibility of implementing some regulation to stop Pharma or clean up Academia. Those are good, but in the end, money talks. I hope you're right!

Thanks to Anonymous and Barney Carroll for the source and correct wording of the quote I used.

I totally agree with paying for CME. I value knowledge and I think its appropriate to pay for it, and have avoided "free" CME for years with the idea that you get what you pay for.

I remember years ago having a trial subscription to a service called Skolar. I log in describe an issue, read journal articles I searched for on the National Library of Medicine, and then type up a summary of what I had learned and how much time I had spent. My submission would be reviewed and I would be given CME credit. Unfortunately the service was discontinued.

That was the most useful CME I ever got because it was my own searching on what was relevant to me and I had to summarize the material (no bubble test).

I still do that, research issues using Pubmed and then my volunteer faculty status to see copies of the full articles on line, and its worth it even though I don't get CME.

But I would pay a lot for a service like Skolar. Perhaps if they didn't have to compete with "free" CME that would be a viable model.

So to recap highlights of the blog thus far:1. Universities and researchers should not derive (much) benefit from their discoveries.2. Drug companies are exiting CNS discovery at a rapid and accelerating pace.3. Current treatments other than talk therapy don't work well (even when they're not causing death or other badness).

So who, exactly, is going to pay to address #3, given #1 and 2? Ah, yes, NIMH (or maybe Biederman or Nemeroff?). Funny, we don't hear much about the NIMH budget and priorities in these discussions.

Turns out it really is all about money. Someone does need to pay for research. Pipets, notebooks, all that science-y stuff. Clinical trials, too. Not to mention salaries for those greedy researchers who do the work, clinical and otherwise.

Or we could just sit around listening intently to our patients and nodding. It worked so well in the 50s...

I know Big Pharma is like the Evil Empire to y'all, but I depend on the medications they produce to make it through my days, as do many others in my situation. If y'all can't play well together, then you'll have to learn. Research for new treatments can't be slowed. If, in 20 years, I'm taking the same side-effect ridden crap drug cocktail, I'm gonna be pissed.

Big Pharma can quit being the "evil empire" when they start doing blind placebo studies against other psychotropics, against placebo's with active ingredients and when they quit relabeling drugs for different purposes purely for economics, rather than client needs. It's not that the Pharma companies don't provide some good products, but all of them spend more on marketing than R&D.

If you look at research unbiased by the vested interest, they don't always hold up, or are far more lackluster then promoted by the Pharma industry.

Let's be clear, look at Abilify/Seroquel now being marketed as an Anti-depressant for "hard to treat depression". Supposedly this works on the Dopamine 2 receptor, but in practice its what I would call a "dirty" drug that hits all kinds of receptors and has severe side effects in a very large portion of those who take it, including a powerful sedative effect. This was just an atypical anti-psychotic, UNTIL its patents wore off and it can be re-patented for a different use, even if the Neuroscience behind it is total garbage.

Electroshock treatment also has some very limited usefulness with some specific cases/neurological issues--but its not given out to everyone that's depressed.

If you look at the research it's pretty scary, and if you see how high up the food chain the pay-off's take place it makes you hesitant. When one pill can make 5 billion dollars in a year profit, and years later its found not to be statistically significant in terms of reducing depressive symptoms when compared to Active ingredient (placebo's that have side effects that help the use to 'believe' in its effects) in European studies...

How about changing the molecular structure and being allowed to re-patent as something "new" although the chemical structure remains the same for purposes of efficacy? This all happens, because the goal is to maximize profit--not to maximize human wellness--sometimes things help, but if they don't--they don't care as long as they can sell their pills. Thus, Bipolar II being handed out to children in droves this past decade, and of course--no biological testing, not even the blood tests that SHOULD be given when on Atypicals--that's the type of stuff that make's me wish there was more Medical in the Psychiatrists I've seen, and less 10minute, 3-4 question, "AHA I know your Neurochemistry and that your 6 year old liver surely can handle 600mg of Seroquel a Day, Oh, I better give another 200mg at night, to help make up for all those amphetamines we gave you to try and force you to be alert in school..."

Hey Lisa: Big Pharma will ensure that 20 years from now you will be taking a new cocktail to get you through your day, with the same crappy side effects! But maybe disclosure will be more mandated as the side effects you can expect(and pay for)!

I understand where you are coming from. But if you want to avoid taking “the same side-effect ridden crap drug cocktail” 20 years from now, then academic psychiatrists will need to quit being shills for the marketing arms of pharmaceutical and device companies. A company sponsored experimercial is not clinical science - it is a studiously disguised marketing exercise. When a KOL like Nemeroff makes false claims to pimp Risperdal for depression through a scientific journal that he controls or when he glosses over the toxicity of Seroquel for depression in a sponsored CME program, you are just being set up for side effects without much in the way of benefit.

"Researchers and their institutions are focusing too much on targeted, applied research, mainly drug development, and not enough on non-targeted, basic research into the causes, mechanisms, and prevention of disease."

It's worse than that; even the researchers conducting basic medical research MUST put a huge dollop of "translational research" spin into their NIH grant applications. It is a open secret that refusing to attend to this "message" will decrease your chances of getting the resources you need to keep the lab open.

It is easy to imagine the corroding influence this can have on basic research; selection bias in the potential subjects to explore, no chance of thinking truly outside the box, which is supposed to be one of the main characteristics of basic research to begin with.

Which brings us back to square one, the industry as a whole wants returns, not cures. Every profession in the world eventually organizes itself into the most efficient revenue streams...we expect medicine to be an exception, but I wonder why? How many would get into this line of work if it paid poorly?